GalaFLEX 3DR 100043-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810054980049), received between Sep 28, 2022 and Aug 27, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Patient-Device Incompatibility

  Attorney alleges that the patient underwent surgery for bilateral breast reconstruction and bilateral inframammary fold reconstruction and soft tissue support on (b)(6) 2025, during which a GalaFlex 3DR mesh was implanted. Within weeks of implantation, the GalaFlex mesh was scheduled to surgically excised due to the reported severe nerve pain, scar tissue, limited range of motion in right arm and disability caused. Patient was injured severely and permanently. As alleged, the patient experienced mental anguish and pain. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." It is also alleged that the device was defective.

  Patient problems: Loss of Range of Motion; Neuralgia; Scar Tissue

  MAUDE report 50474381 ↗
• InjuryAug 27, 2026Patient-Device Incompatibility

  Attorney alleges that the patient underwent surgery for bilateral breast reconstruction and bilateral inframammary fold reconstruction and soft tissue support on 18-Jun-2025, during which a GalaFlex 3DR mesh was implanted. Within weeks of implantation, the GalaFlex 3DR mesh was scheduled to surgically excised due to the reported severe nerve pain, scar tissue, limited range of motion in right arm and disability caused. Patient was injured severely and permanently. As alleged, the patient experienced mental anguish and pain. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." It is also alleged that the device was defective.

  Patient problems: Loss of Range of Motion; Neuralgia; Scar Tissue

  MAUDE report 50474380 ↗
• MalfunctionJun 16, 2026Material Split, Cut or Torn

  AS REPORTED ON (B)(6) 2026, ONE PIECE OF GALAFLEX 3DR SCAFFOLD WAS USED BY THE SURGEON. WHILE FOLDING, IT WAS OBSERVED THAT THE RIM ALMOST CAME OFF. DUE TO THIS, ANOTHER PIECE WAS OPENED BY THE SURGEON, AND THE RIM CAME OFF IN FEW SPOTS, AND THE SURGEON OPTED TO PROCEED WITH THE IMPLANTATION WITH IT. ADDITIONALLY, IT WAS OBSERVED THAT THE MESH WAS LESS STRETCHY AND FELT DIFFERENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25518454 ↗
• MalfunctionMay 13, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A SURGERY, THE EDGES OF GALAFLEX 3DR FELL OFF, WITHOUT THE CUSTOMER CUTTING THEM. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160277 ↗
• InjuryMar 19, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: A 33-YEAR-OLD FEMALE PATIENT HAD IMPLANT MALPOSITION THEREBY UNDERWENT BILATERAL IMPLANT CONVERSION TO SUBGLANDULAR POCKET, BILATERAL WISE PATTERN MASTOPEXY WITH THE BILATERAL IMPLANT OF TWO GALAFLEX 3DR SCAFFOLD (DEVICE 1 AND 2) AND TWO ALLERGEN STYLE SSX NATRELLE INSPIRA SOFT TOUCH ON (B)(6) 2024. PER OP NOTES, ¿PATIENT DID TEST POSITIVE ON A URINE NICOTINE TEST. PREVIOUSLY PLACED IMPLANT WAS REMOVED. ON THE RIGHT SIDE, THE IMPLANT WAS IN A FLIPPED POSITION, THE CAPSULE DID EXTEND BENEATH AND OVER THE PECTORALIS MAJOR MUSCLE. AT THIS POINT, PERFORMED A CAPSULECTOMY OFF THE CHEST WALL, THE GALAFLEX 3DR SCAFFOLD (DEVICE 1) AND SOFT TOUCH XTRA IMPLANT WERE PLACED. ON THE LEFT SIDE, THE PECTORALIS MAJOR MUSCLE WAS SLIGHTLY MORE ADVANCED, ALTHOUGH THERE WAS STILL A SMOOTH CAPSULE ABOVE THE PECTORALIS MAJOR MUSCLE. PERFORMED A CAPSULECTOMY, CAPSULORRHAPHY, AND CAPSULOTOMY IN A SYMMETRICAL FASHION AS THE RIGHT SIDE. SECURED GALAFLEX 3DR SCAFFOLD (DEVICE 2) TO THE CHEST WALL ALONG ITS INFERIOR BORDER. A SYMMETRICAL MASTOPEXY AND IMPLANT PLACEMENT WERE PERFORMED ON THE CONTRALATERAL SIDE.¿ (B)(6) 2024 ¿ PATIENT HAD EXTREME PAIN. (B)(6) 2024 ¿ IN CT SCAN, IT LOOKS

  Patient problems: Bacterial Infection; Fever; Pain; Swelling/ Edema

  MAUDE report 24641108 ↗
• InjuryJun 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility; Incorrect, Inadequate or Imprecise Result or Readings; Patient-Device Incompatibility

  AS REPORTED, DURING BILATERAL BREAST REVISION AUGMENTATION SURGERY, THE PATIENT WAS IMPLANTED WITH 775 IMPLANTS AND GALAFLEX 3DR (DEVICE #1 & #2) FOR SOFT TISSUE SUPPORT ON (B)(6) 2022. IT WAS REPORTED THAT SURGEON CONFIRMS THAT THERE WAS MESH LUMPS ON BOTH SIDES. THE GALAFLEX WAS NOT SUTURED IN PLACE. THE PATIENT HAS ¿BOTTOMED OUT ¿ AND CAN STILL FEEL THE GALAFLEX "VERY EASILY.¿ IT WAS REPORTED THAT THE PATIENT AND THE SURGEON ARE CONCERNED THAT THE PRODUCT DID NOT INTEGRATE AS EXPECTED AND PLANS TO REMOVE THE MESHES SOON.

  Patient problems: Ptosis

  MAUDE report 19557062 ↗
• InjuryNov 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BILAT BREAST IMPLANT EXCHANGE AND BREAST LIFT ON (B)(6) 2022. AS REPORTED, THE PATIENT PRESENTED SHORTLY AFTER THE PROCEDURE WITH BOTH BREAST DROPPING SIGNIFICANTLY AND NOT LIFTED AS EXPECTED. AS REPORTED, THE SURGEON WOULD LIKE TO REPAIR THE PATIENT'S BREASTS, BUT HE CANNOT AT THIS TIME SINCE THE GALAFLEX HAS NOT FULLY RESORBED.

  Patient problems: Physical Asymmetry

  MAUDE report 15729608 ↗
• InjurySep 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH GALAFLEX IN (B)(6) 2020 ADDED TO A BREAST LIFT. IT WAS REPORTED THAT IMMEDIATELY AFTER SURGERY, THE PATIENT EXPERIENCED CONSTANT PAIN. THE PATIENT REPORTED THE BREAST LIFT FAILED IN REGARDLESS OF THE MESH IMPLANT, AND OVER THE NEXT FEW MONTHS THE MESH WAS SEEN ABOVE THE SKIN. IT WAS ALSO REPORTED THAT IT REMAINED THAT WAY FOR TWO YEARS POST OP AND THE PATIENT IS LEFT WITH PAIN. THE PATIENT ALSO STATES THAT AFTER ADDING IMPLANTS IT HAS FAILED FURTHER.

  Patient problems: Pain

  MAUDE report 15500018 ↗